MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number UNK-NV-CONCERTO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 02/27/2023

Event Type  Death  

Event Description

Zacà s, patruno i, pulli r, angiletta d.Endovascular repair using parallel grafts to treat a suprarenal pancreatitis-related abdominal aortic pseudoaneurysm.Catheterization and cardiovascular interventions: official journal of the society for cardiac angiography <(>&<)> interventions.2023;101(5):888-891.Doi:10.1002/ccd.30624.Medtronic literature review found a report of patient complications in association with a concerto coil.The purpose of this article was to describe a contained rupture of a suprarenal abdominal aortic pseudoaneurysm.An aorto-uni-iliac stent-graft was adopted as the aortic main body and was combined with two chimneys and two periscope stents for celiac/superior mesenteric artery and renal arteries, respectively.The procedure was complicated by the entrapment of the celiac sheath into the barbs of the aortic stent-graft and the attempts to remove the sheath resulted in an upward migration of the stent-grafts.A bail-out endovascular procedure was used to reline the stent-grafts and the pseudoaneurysmal sac was embolized with concerto coils.The article does not state any technical issues during use of the concerto coil.The following intra- or post-procedural outcomes were noted:  - the patient died 10 months after the intervention as a result of myocardial infarction.The postoperative period was uneventful.At 6 months follow-up the patient was healthy, and the ct scan confirmed the exclusion of the aortic lesion and the patency of all the stent-grafts.No endoleak/ gutters were observed, and the asymptomatic occlusion of the celiac artery stent was confirmed.

Manufacturer Narrative

Zacà s, patruno i, pulli r, angiletta d.Endovascular repair using parallel grafts to treat a suprarenal pancreatitis-related abdominal aortic pseudoaneurysm.Catheterization and cardiovascular interventions: official journal of the society for cardiac angiography <(>&<)> interventions.2023;101(5):888-891.Doi:10.1002/ccd.30624 e1.Street 1 (cont.): bari- italy piazza giulio cesare 11.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the adverse event was related to the medtronic product but it was related to the surgeon's maneuver to obtain the disengagement of the sheath through the barbs of the top bare metal stent.

• Brand Name: CONCERTO
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17025035
• MDR Text Key: 316192062
• Report Number: 2029214-2023-00865
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-CONCERTO
• Device Catalogue Number: UNK-NV-CONCERTO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Female